Regulatory Framework

“Eight central Ethics Review Committees (ERC) accredited by the Ministry of Health, out of which three are accredited by WHO. Legislation for conducting clinical trials in Sri Lanka that have been developed in line with ICH-GCP requirements and guidelines ( shows the state oversight. All studies require approval from one of the accredited central ERCs. The National Medicines Regulatory Authority (NMRA) of the Ministry of Health provides regulatory oversight.

In order to initiate a clinical trial in Sri Lanka, approval from the Sub-Committee on Clinical trials (SCOCT) of the NMRA, Ministry of Health (MOH), can be obtained within a period of 4-6 weeks upon receiving clearance from one of the Ethics Review Committees. The approval offered by SCOCT is valid for 5 years and extensions of time be requested from SCOCT, no less than 60 days from the expiration of the initial approval.”

Centralized ethics approval

Legislation for trial conduct

WHO Hardened trial registry average regulatory & ethics approvals time line; 6 weeks